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RHOPHYLAC Solution for injection (2019)

Active ingredients: Anti-D (rh) immunoglobulin

Product Name and Form

Rhophylac 300 micrograms/2 ml, solution for injection in pre-filled syringe.

Pharmaceutical form

Solution for injection.

The solution is clear or slightly opalescent and colourless or pale yellow.

Rhophylac has an osmolality of at least 240 mosmol/kg.

Qualitative and Quantitative Composition

Each pre-filled syringe contains 300 micrograms (1500 IU) human anti-D immunoglobulin*.

One ml contains 150 micrograms (750 IU) human anti-D immunoglobulin.

The product contains a maximum of 30 mg/ml of human plasma proteins of which 10 mg/ml is human albumin as stabiliser. At least 95% of the other plasma proteins are IgG.

Distribution of the IgG subclasses (approximate values):

IgG1: 84.1%
IgG2: 7.6%
IgG3: 8.1%
IgG4: 1.0%

The content of immunoglobin A (IgA) is not more than 5 micrograms/ml.

* Produced from the plasma of human donors.

Excipient with known effect:

This medicine contains less than 1 mmol sodium (23 mg) per syringe, that is to say essentially “sodium-free”.

Rhophylac contains no preservatives.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Anti-D (rh) immunoglobulin

Human anti-D immunoglobulin contains specific antibodies (IgG) against the Rh(D) antigen of human erythrocytes. It can also contain antibodies to other Rh antigens, e.g. anti-Rh C antibodies. The mechanism by which anti-D immunoglobulin suppresses immunisation to Rh(D) positive red cells is not known.

List of excipients

Human albumin
Glycine
Sodium chloride
Water for injections

Pack sizes and Marketing

2 ml solution in a pre-filled syringe (type I glass) with 1 injection needle in a pack size of 1 or in a multi-pack consisting of 5 single packs.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany

01 June 2006

Marketing authorization number:

PL 15036/0019